Since the availability of the rotavirus vaccine and July 7, 1999, 15 cases of intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment) were reported to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a passive surveillance system operated by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). Vaccine manufacturers are required to report to VAERS any adverse event reported to them, and health-care providers are encouraged to report any adverse event possibly attributable to a vaccine.
Before the rhesus rotavirus vaccine-tetravalent (RRV-TV) (RotaShield) was licensed for use in the United States, five cases of intussusception had occurred among 10,054 vaccine recipients and one of 4,633 controls, a difference that was not statistically significant. On the basis of these data, intussusception was included as a potential adverse reaction on the package insert.
On October 22, 1999, the Advisory Committee on Immunization Practices (ACIP) concluded that intussusception occurs with significantly increased frequency in the first 1-2 weeks after vaccination with RRV-TV, particularly following the first dose. Therefore, ACIP no longer recommends vaccination of infants in the United States with RRV-TV and withdraws it recommendation that RRV-TV be administered at 2, 4, and 6 months of age. Children who received rotavirus vaccine before July and remain well are not now at increased risk for intussusception.
Intussusception among recipients of rotavirus vaccine — United States, 1998-1999, MMWR 48(27):577-581, July 16, 1999
Withdrawal of rotavirus vaccine recommendation, MMWR 48(43): 1007, Nov 5, 1999.
Rotavirus Vaccine Drug Card Update
See Chapter 10 in Essentials of Pediatric Nursing, 5th edition.
See Chapter 12 in Nursing Care of Infants and Children, 6th edition.
March 15, 2002